A Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in the Treatment of Recurrent and Metastatic HNSCC

NCT05044897 | Active Not Recruiting Phase 2

• 1 other identifier: SI-B001_209
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

Brief Summary

This multi-center, open label phase II clinical study is performed in patients with recurrent metastatic squamous cell carcinoma of the head and neck progressed on prior anti-PD-1 mab ± platinum-based chemotherapy. This study is investigating the safety and efficacy of SI-B001 as a single agent in patients.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

HNSCC

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response Rate

  Up to 2 weeks

Secondary Outcomes (9)

• DOR

  Up to 2 years

• PFS

  Up to 2 years

• DCR

  Up to 2 years

• OS

  Up to 2 years

• TEAE

  Up to 2 years

Study Arms (1)

Study treatment

EXPERIMENTAL

SI-B001 is a bispecific antibody targeting EGFR and HER3, which is administered weekly by intravenous infusion（QW）. The 4-week cycle was maintained until disease progression or cessation due to intolerable toxicity or other reasons (e.g., withdrawal of informed consent or death). From C1D1, efficacy was evaluated every 8 weeks ±7 days in the first year and every 12 weeks ±7 days in the second year.

Drug: SI-B001

Interventions

SI-B001 DRUG

administration weekly by intravenous infusion（QW）.

Study treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign the informed consent voluntarily and comply with the requirements of the program;
• Age ≥18; Gender is not limited;
• Expected survival time ≥3 months;
• Locally advanced squamous cell carcinoma of the head and neck confirmed by histology or pathology as recurrent metastatic or without indications of radical local treatment;
• Patients who failed or were intolerant to previous anti-PD-1 mab and platinum-containing chemotherapy
• Treatment failure of PD-1 refers to disease progression during or after PD-1 treatment.
• Failure of platinum-containing chemotherapy refers to:
• disease progression during or after platinum-containing chemotherapy;
• recurrence or disease progression within 6 months of platinum-containing multi-mode therapy;
• Agree to provide tumor tissue samples (FFPE block or 10 unstained sections of 5μm size) or fresh tissue samples archiving within one year from primary or metastatic foci. If the patient fails to provide the samples, they can be included after the investigator's judgment;
• There must be at least one measurable lesion in accordance with the RECIST v1.1 definition. Tumor lesions located in the area of previous radiotherapy or other local regional treatment sites are generally not measurable unless there is definite progression of the lesion or the lesion persists three months after radiotherapy;
• Physical fitness ECOG score 0 or 1;
• Adverse reactions to previous antitumor therapy were restored to CTCAE 5.0 ≤1 (except for toxicity judged by the researchers to be of no safety risk, such as hair loss, grade 2 peripheral neurotoxicity, and stable hypothyroidism after hormone replacement therapy);
• Organ function levels must meet the following requirements and meet the following standards:
• Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10\*9/L, platelet count ≥75×10\*9/L, hemoglobin ≥90 g/L;

You may not qualify if:

• Squamous cell carcinoma with primary site of nasopharynx or skin;
• Have received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor therapy within 4 weeks prior to the first use of the study drug, except the following:
• Nitrosorea or mitomycin C within 6 weeks before the first administration of the study drug;
• Oral fluorouracil and small molecule targeted drugs are 2 weeks before the first administration of the study drug or within the 5 half-lives of the drug (whichever is longer);
• The traditional Chinese medicines with anti-tumor indications were within 2 weeks before the first use of the study drug;
• Received an unmarketed clinical investigational drug or treatment within 4 weeks prior to the first use of the investigational drug;
• Has undergone major organ surgery (excluding needle biopsy, tracheotomy, gastrostomy, etc.) or has significant trauma within 4 weeks before the first use of study drugs, or needs to undergo elective surgery during the trial;
• Previous recipients of allogeneic hematopoietic stem cell transplantation or organ transplantation;
• A history of serious cardiovascular and cerebrovascular diseases, including but not limited to:
• Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, grade iii atrioventricular block, etc.
• In the resting state, QT interval was prolonged (QTc \> 450 msec in men or QTc \> 470 msec in women).
• Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 or higher cardio-cerebrovascular events within 6 months prior to the first administration;
• New York Heart Association (NYHA) heart function grade ≥II heart failure;
• Active autoimmune diseases and inflammatory diseases, such as: systemic lupus erythematosus, systemic treatment of psoriasis, rheumatoid arthritis, inflammatory bowel disease, and hashimoto's thyroiditis, etc., with the exception of type I diabetes, only replacement therapy can control the hypothyroidism, no systemic treatment of skin disease (e.g., vitiligo, psoriasis);
• A history of other malignancies within 5 years prior to first administration, except for radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or radical excised carcinoma in place, and second primary squamous cell carcinoma of the head and neck;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead

Study Sites (3)

The Second Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China

Location

The Affiliated Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Location

Shanghai Oriental Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Ye Guo

  Shanghai Oriental Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: September 16, 2021
• Study Start: October 20, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)